HD14 for intermediate stage Hodgkin's disease: Quality assurance protocol to increase effectiveness in the first-line treatment of intermediate stage Hodgkin's disease

Conditions

Hodgkin's disease Cancer Hodgkin's disease

Stephanie Sasse, Helen Goergen, Annette Plütschow, Boris Böll, Dennis A. Eichenauer et al. (17 authors)

Journal of Clinical Oncology2018-07-107 citations

10.1200/jco.2018.78.7192

Risk factors and a prognostic score for survival after autologous stem-cell transplantation for relapsed or refractory Hodgkin lymphoma.

Bröckelmann PJ, Müller H, Casasnovas O, Hutchings M, von Tresckow B, Jürgens M, McCall SJ, Morschhauser F, Fuchs M, Borchmann P, Moskowitz CH, Engert A.

2017-06-0158 citations

10.1093/annonc/mdx072

Kreissl S, Mueller H, Goergen H, Mayer A, Brillant C, Behringer K, Halbsguth TV, Hitz F, Soekler M, Shonukan O, Rueffer JU, Flechtner HH, Fuchs M, Diehl V, Engert A, Borchmann P, German Hodgkin Study Group.

2016-09-0672 citations

10.1016/s1470-2045(16)30093-6

Interventions

Primary objective: to increase effectiveness Arm A: 4 x ABVD + 30 Gy involved field radiotherapy Arm B: 2 x BEACOPPescalated + 2 x ABVD + 30 Gy involved field radiotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed Hodgkin's disease 2. Stages IA, IB, and IIA with one or more of the following risk factors: 2.1. Massive mediastinal involvement (tumour one third or more of the maximum intrathoracic diameter) 2.2. Extranodal involvement 2.3. High erythrocyte sedimentation rate (ESR) (more than or equal to 50 mm; more than or equal to 30 mm in patients with B symptoms) 2.4. Three or more involved lymph node areas; stage IIB and high ESR (more than or equal to 30 mm) and/or three or more involved lymph node areas 3. No prior therapy for Hodgkin's disease 4. Age: 18 to 60 years 5. No major organ dysfunction 6. Life expectancy more than three months 7. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Incomplete staging 2. Major organ dysfunction (Chronic Obstructive Pulmonary Disease [COPD] with respiratory insufficiency, symptomatic Coronary Heart Disease [CHD], cardiomyopathy or heart failure [ejection fraction less than 50%], severe hypertension, non-treatable infections, white blood count less than 3000/mm^3 or platelets less than 100,000/mm^3, creatinine clearance less than 60 ml/min, bilirubin more than 2 mg/dl, Glutamic-Oxaloacetic Transaminase [GOT]/ASpartate aminoTransferase [AST] more than 100 U/l, Glutamic-Pyruvic Transaminase [GPT]/ALanine aminoTransferase [ALT] more than 100 U/l, Human Immunodeficieny Virus [HIV]-infection) 3. Composite lymphoma 4. Prior chemotherapy or radiotherapy 5. Any history of another malignancy in the last five years (except for cervical carcinoma in situ and fully resected melanoma TNMpT1) 6. Pregnant or lacating women 7. World Health Organisation (WHO) performance status more than two 8. Long term use of corticosteroids (e.g. for arthritis) or antineoplastic substances (e.g. methotrexate) 9. Expected non compliance 10. Current therapy for epilepsy 11. Intolerabilities against study drugs 12. Inability to give truly informed consent

Design outcomes

Primary

Measure	Time frame
Freedom From Treatment Failure [FFTF]	—

Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

Germany

Outcome results

None listed